HIGH
FDA DRUG
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. ...
CHLORTHALIDONE
Failed Dissolution
Drug Recalls Center
2,090 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
2,090
Total Drug Recalls
24
High Risk Medications
FDA
Official Source
Important Medication Safety Information
- Do not stop taking prescribed medications without consulting your healthcare provider
- Contact your pharmacist or doctor if you have a recalled medication
- Check lot numbers carefully - not all batches may be affected
- Return recalled medications to your pharmacy for proper disposal
Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.
HIGH
FDA DRUG
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854,...
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
LACOSAMIDE
Presence of
HIGH
FDA DRUG
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
SENSIPAR
CGMP Deviations
HIGH
FDA DRUG
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles,...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
DULOXETINE
CGMP Deviations:
HIGH
FDA DRUG
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
DULOXETINE
CGMP Deviations:
HIGH
FDA DRUG
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Haleon US Holdings
Chemical Contamination:
HIGH
FDA DRUG
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
CORLANOR
Presence of
HIGH
FDA DRUG
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
POVI-ONE
sub potency
HIGH
FDA DRUG
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
SENSIPAR
CGMP Deviations
HIGH
FDA DRUG
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.
CORLANOR
Presence of
HIGH
FDA DRUG
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
SENSIPAR
CGMP Deviations
HIGH
FDA DRUG
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur...
PREDNISOLONE ACETATE
Presence of
HIGH
FDA DRUG
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal...
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
PRIMIDONE
Cross Contamination
HIGH
FDA DRUG
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in...
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002...
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store...
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New...
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line...
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
HIGH
FDA DRUG
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India
CGMP Deviations;
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